October 26

Congress & the White House must remedy a prescription for danger – LA Times / CBS News

Congress & the White House must remedy a prescription for danger – LA Times / CBS News

Thu, 1 Apr 2004

For those who missed the CBS evening News broadcast (Tues March 30) about FDA’s suppression of evidence, a video of that powerful report can be viewed online. http://www.cbsnews.com/stories/2004/03/30/eveningnews/main609491.shtml

CBS exposed an FDA cover-up of a report validating a twofold suicide risk for children who tested an antidepressant compared to those who received a sugar pill. The evidence, whose existence has been denied by FDA officials and by drug stakeholders–the manufacturers and their paid collaborating psychiatrists–comes from company controlled clinical trials.

Regrettably, few in the national press have been reporting the antidepressant drug story critically or even devoid of misleading comments meant to reassure the public about the safety and benefits of these drugs–even as the FDA was compelled to issue warnings when the cover-up was revealed on February 1, 2004, in the San Francisco Chronicle. See: http://psychrights.org/Articles/SFChronicalreportbarredbyFDA.htm

It is fair to ask, why most senior science writers in the national press (not to mention the journals) have been duped into writing favorable reports sprinkled with false claims and misleading reassurances about the safety and effectiveness of antidepressants and any number of other drugs? (“Studies in children taking the antidepressants have not found an increase in suicide” “After all, suicides are rare enough that there are no firm human data on whether the drugs can cause them.”)

How do senior science reporters justify their failure to examine the evidence or to raise doubts about unsubstantiated claims made by their sources who have a stake in the company whose drug product they laud?

A major investigative report by Kevin Sack (formerly of The New York Times) and Alicia Mundy (author of Dispensing With the Truth, a book about the battle over Fen-Pen), appeared on Sunday, March 28, in the Los Angeles Times. These two first rate investigative reporters examined thousands of pages of documents, uncovering incriminating evidence adding weight to a growing body of evidence that demonstrates the lethal consequences of collusion between FDA officials and the drug industry.

The focus of the LA Times report is on the failure of FDA’s over the counter division to take action to protect the public when it had evidence that drugs containing the stimulant phenylpropanolamine (PPA), used in popular over the counter cold medicines and diet pills, had “the ability to cause cardiovascular effects, cerebral hemorrhage and cardiac arrhythmias.” Lives were sacrificed to maintain sales.

Just as FDA officials knew of the suicidal risks of antidepressants (at least since 1996) and pretended not to know, the LA Times reports that agency officials knew of the risks at least since early 1982. The LA Times reports that industry officials and FDA officials knew that hundreds of people would suffer debilitating strokes from products containing PPA, yet they failed to take action until late 2000. See: A Dose of Denial By Kevin Sack and Alicia Mundy, was published on Sunday, March 28 2004.

Below is Monday’s LA Times editorial calling for Congress and The White House to take action to protect us from dangerous, even lethal drugs since the FDA has demonstrably failed to do so.

Contact: Vera Hassner Sharav
Tel: 212-595-8974

CBS evening NEWS with Dan Rather
FDA Mum On Suicidal Side Effects?
WASHINGTON, March 30, 2004
FDA Mum On Suicidal Kids?
CBS News Correspondent Sharyl Attkisson

According to documents obtained by CBS News, there were twice as many suicide-related events in children who took antidepressants as those who got only sugar pills.

Read reports on FDA antidepressant and suicide research:

(CBS) Congress is investigating whether the FDA — which is supposed to protect the public — sat on medical evidence and failed to act quickly on a possible link between anti-depressants and suicidal behavior in children, reports CBS News Correspondent Sharyl Attkisson.

With ten million American kids a year prescribed Paxil or other popular anti-depressants, the question of whether the drugs actually cause suicidal behavior in children is crucial.

Last summer, a link was revealed in data from Paxil’s maker, GlaxoSmithKline.

“It has us worried,” said an FDA internal document.

So the FDA assigned one of its respected medical officers, Andrew Mosholder, to look at studies of eight anti-depressants and thousands of troubled kids.

What he found added fuel to the fire.

According to documents obtained by CBS News, there were twice as many suicide-related events in children who took antidepressants as those who got only sugar pills.

Mosholder called the findings “difficult to dismiss.” But the public never got to hear those results. As Mosholder prepared to report to this FDA panel last month, there was an incredible turn of events.

Sources claim Mosholder’s FDA bosses intervened and “pressured him to change his conclusions” to make them “ambiguous and less definitive.”

At the last minute, they took his report off the agenda entirely.

Word of Mosholder’s findings got out to the media anyway. That’s when FDA managers launched a criminal investigation to find which employees leaked the report. Even though, according to one source, “it’s clearly information the public should have.”

Earlier this month, the FDA issued a warning on anti-depressants and suicide, but watered it down by implying there was really no strong evidence — making no mention of Mosholder’s findings.

Patient advocate with the Alliance for Human Research Vera Hassner Sharav says top FDA officials are watching out for the drug industry, not consumers.

“What we want to know is why the FDA has been sitting on this evidence and pretending, now after all this time, there is no evidence,” Sharav says.

Congress is asking the same questions. Did the FDA try to suppress a link between anti-depressants and suicidal behavior in kids, and did it try to intimidate employees who exposed the risks.

* Sen. Grassley’s Report (pdf format)

* Energy & Commerce Committee Letter

CMMIV, CBS Broadcasting Inc. All Rights Reserved.

March 30, 2004


A Prescription for Peril

The story of drug makers’ two-decade struggle to keep cold medicines and diet products laced with phenylpropanolamine, or PPA, on store shelves highlights the need for Congress to create stronger firewalls between drug industry funding and research.

As Times staff writers Kevin Sack and Alicia Mundy reported Sunday, since at least 1982 the Food and Drug Administration knew this stimulant could cause some people to suffer cardiovascular effects, cerebral hemorrhage and cardiac arrhythmias. A landmark study designed – and thereafter concealed – by the industry concluded as much in 1999.

Still, the agency only began to take pusillanimous steps toward pulling the drug off the shelves in late 2000.

In their defense, drug makers blame the FDA. Typical is this comment by Robert G. Donovan, the former head of Sandoz Consumer Health Care, a drug maker that knew the dangers of PPA at least as far back as 1984: “My assumption was that if there was an issue of safety, supported by sound evidence, that the Food and Drug Administration would exercise their responsibility and take the product off the market.”

The FDA counters that the industry hampered it. Because the agency does not sponsor research, its officials say, it must rely on the industry to investigate the safety of its own products. And because the industry managed to delay publication of research, there was insufficient evidence of PPA’s dangers to take it off the market or demand label warnings.

Congress must step in, recognizing that people are dying while fingers are pointing.

Congress, ideally, would create an Office of Clinical Research, a federal institute to act as an ethical buffer. Funded in part by industry dollars that now flow directly to individual scientists (thus corrupting their results), the institute would test new drugs against older ones. New drugs now are compared only with inert pills or placebos in clinical trials designed by pharmaceutical firms. As envisioned by medical policy experts such as Drummond Rennie, a deputy editor of the Journal of the American Medical Assn., the institute would reserve its seal of approval only for drugs that prove superior to existing drugs.

Congress is unlikely to act so boldly in this election year, but it should at least hold hearings to examine why the Food and Drug Administration gives drug firms such sway. Though it may be appropriate to let them help design studies, their influence should end there. And drug firms should not dictate timing of a study’s release.

Legislators also should ask why, when PPA’s dangers became clear, the agency did not move it to prescription-only status. This lapse is especially troubling with a nonessential, replaceable over-the-counter drug. It’s also disconcerting how this case shows the FDA lacks a sound system for doctors and hospitals to raise alarms about “adverse events” in patients using drugs, like PPA, that long have been available over the counter.

Whether with easily obtained drugs like PPA, or with problem prescription items like the diabetes treatment Rezulin, or with its shaky regulation of herbal nostrums, the FDA shows itself to be more industry lapdog than safety sentinel.

That’s a prescription for danger that Congress and the White House must remedy.

FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

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